In a Perspective article published today in the New England Journal of Medicine, Cobb and Abrams conclude that because of its ineffective nicotine delivery, electronic cigarettes are unlikely to be useful in attempts to quit smoking.

According to the article: "testing of users in laboratory settings revealed minimal blood nicotine concentrations. Marketing claims aside, the devices tested did not efficiently deliver nicotine, much less deliver it into the arterial blood as tobacco smoke does. Smokers attempting to use e-cigarettes for smoking cessation will most likely find them ineffective; indeed, their use may instead perpetuate smokers' addiction."

The article argues that there are already many effective treatments for smoking cessation available: "In reality, both smokers and e-cigarette users have many alternatives: multiple nicotine products, approved, regulated, and deemed to be safe and effective by the FDA, are already widely available (in addition to other effective cessation tools, such as varenicline, bupropion, telephone quit-lines, and Web-based services)."

The article advises physicians to recommend against the use of electronic cigarettes: "clinicians should advise patients wishing to use nicotine to stick to the FDA-regulated forms, such as patches, gum, lozenges, nasal spray — or even, perhaps, the existing FDA-approved inhaler."

The Rest of the Story

The article is problematic for two major reasons.

First, it draws a conclusion -- that electronic cigarettes are unlikely to be effective in helping smokers quit -- based on no supporting evidence. In fact, the article ignores the overwhelming number of reports from actual individuals who have used electronic cigarettes successfully to quit smoking. Instead, it relies on a single study which under unrealistic conditions, found ineffective delivery of nicotine from an electronic cigarette among novice users.

The article's perspective is flawed because it only recognizes one aspect of addiction to cigarettes: the pharmacologic addiction to nicotine. It ignores the fact that there is a strong behavioral aspect to the addiction. The physical stimuli, the various acts associated with smoking, the social factors, are all part of the addiction. In fact, electronic cigarettes are effective for many smokers specifically because they mimic the behavioral act of smoking and thus address the behavioral and not merely the pharmacologic aspect of the addiction.

Instead of concluding that electronic cigarettes are unlikely to help smokers quit, the article should instead have noted how remarkable it is that a product which appears to deliver nicotine relatively ineffectively has been so effective in helping many smokers to quit. So much so that there are internet forums with thousands of vapers who testify to the effectiveness of these devices in keeping them off cigarettes completely, many of them for more than a year. With technological refinements that would improve nicotine delivery, the effectiveness of the product will only improve.

It is surprising that the article would draw a conclusion regarding the ineffectiveness of electronic cigarettes in helping smokers quit without actually reviewing the substantial evidence -- put forward by literally hundreds of ex-smokers -- that the electronic cigarette is what enabled them to quit smoking. In order for Cobb and Abrams' conclusion to be true, these hundreds of electronic cigarette users must apparently be lying.

It is interesting that while the authors completely discount hundreds of reports of the effectiveness of electronic cigarettes for complete smoking cessation, they are willing to put out dire warnings about the dangers of the product in the absence of a single reported case of nicotine toxicity - or any other serious adverse effect - caused by electronic cigarettes, despite their use by more than a million people over the past four years, and despite the failure of the FDA to report any serious adverse effects for two years following its urging of vapers to report such effects to the agency.

The second problem with the article is that it makes what I feel is an irresponsible medical recommendation: that ex-smokers who have quit successfully using the electronic cigarette discontinue the use of these devices and switch over to an FDA-approved therapy, like the nicotine patch.

The rest of the story is that the majority of these successful ex-smokers have tried FDA-approved therapies and failed. This is precisely why they have given electronic cigarettes a try. People do not generally pick up an electronic cigarette for $40 to $90 in a first attempt to quit smoking. Usually, they try the FDA-approved therapies first, get frustrated that they don't work well, and then decide to try an unconventional approach. It is almost undoubtedly true that if vapers stopped using electronic cigarettes and switched over to the nicotine patch or gum, most of them would end up smoking cigarettes within hours to days.

This is why I call it irresponsible advice: the result would be literally thousands of ex-smokers returning to regular cigarette smoking. It would be essentially a public health disaster. The complete reversal of tremendous health gains that these vapers have already realized. What a shame it would be to have thousands of these ex-smokers negate their success in quitting smoking and return to the analog cigarettes because of some unsupported and ill-thought-out advice that somehow they are worse off being ex-smokers on e-cigarettes than current smokers on Marlboros.

But the real shame of this story is that the ill advice is not coming from individuals who are objective and financially unconflicted. It is coming from authors who I believe have financial conflicts of interest that could be perceived as potentially biasing them to protect the profits of traditional smoking cessation approaches.

Dr. Cobb is a paid consultant to a company that makes its profits based on an internet smoking cessation site which heavily promotes smoking cessation drugs: "Dr Cobb is a consultant to Healthways Inc, the current owner of the QuitNet system." Thus, he is conflicted because to the extent that the use of electronic cigarettes presents a different pathway to cessation than the traditional one - the use of a smoking cessation internet site, medication, online support, etc. - e-cigarettes may represent a threat to the profits of Healthways. In this light, it is perhaps not surprising that "Web-based services" are called out in the article as an existing smoking strategy that should be relied upon instead of electronic cigarettes.

Dr. Abrams has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Dupont Merck, Glaxo-Wellcome, SmithKline Beecham, Sano Corporation, Bristol-Myers Squibb, Knoll Pharmaceuticals, and Pfizer. Dr. Abrams also reports having served as a senior scientific advisor for Johnson & Johnson. It is difficult to find a pharmaceutical company involved in smoking cessation drugs that Dr. Abrams has not had an association with over the years.

This is not to criticize him; the research has made important contributions. It is simply to make note of the financial conflicts of interest that are present with respect to his views on electronic cigarettes, a major threat to the profits of these very same pharmaceutical companies.

The bottom line is that the article draws a major conclusion which lacks supportive evidence and which ignores substantial evidence, that it advances a piece of medical advice which is ill-chosen and could be harmful to many people, and that both of these problems appear in the setting of substantial financial conflicts of interest.

Wednesday, July 20, 2011

Earlier this year, I criticized the Tobacco Products Scientific Advisory Committee (TPSAC) for failing, in its menthol cigarette report, to make a recommendation to the FDA regarding what action the agency should take. Recently, the Committee had a second chance to make a recommendation. Of its own initiative, the Committee requested an opportunity to issue an amended report with a number of changes.

When I first learned that TPSAC wanted to issue an amended report, I considered the possibility that maybe the committee took to heart the nation's reaction -- that the report did not in fact include any recommendation that the FDA ban or proceed to ban menthol cigarettes -- and decided to definitively clarify the issue. The chair of the committee had stated in a newspaper article, in response to my criticism, that the committee did in fact make a clear recommendation. I thought that perhaps the committee was taking advantage of this opportunity to make its recommendation clear to the public and to the FDA.

No such luck, however. The changes in the report were minor, and they did not alter the report's failure to deliver a recommendation on what policy the FDA should adopt regarding menthol cigarettes.

The report's "recommendation" remained a self-evident conclusion rather than a recommendation: removing menthol cigarettes from the market would benefit the public's health.

As I explained earlier, this is a conclusion, not a recommendation. I could just as easily conclude that removing all cigarettes from the market would benefit the public's health. That may be true, but it does not amount to a recommendation that cigarette sales be prohibited. One can believe that removing cigarettes from the market would benefit the public's health and still be free to either recommend a ban on cigarettes or not to recommend such a ban.

Thus, the simple statement that removing menthol cigarettes from the market would benefit the public's health does not amount to a recommendation either way. In fact, the report goes on to insist that it has no particular position on the issue or advice to the FDA, other than that the agency be sure to consider the potential contraband effects of a menthol ban if it does consider such a policy.

The Rest of the Story

The rest of the story is that, once again, the TPSAC has shirked its Congressionally-mandated responsibility to weigh the costs and benefits of a menthol cigarette ban and instead, it has again punted the issue right back to the FDA. This leaves the agency with little choice other than to initiate its own review of the issue and make its own decision. In fact, this is precisely what the agency announced it will now do. Thus, the TPSAC's report and deliberations were largely a waste of time and resources, as I argued previously.

The TPSAC has played perfectly into Philip Morris' hands by displaying the utmost of bureaucratic piddling and diddling. Knowing that it would be almost impossible to get a menthol ban promulgated via administrative actions by federal agencies, Philip Morris happily agreed to a compromise Tobacco Act that exempted menthol from its flavoring ban but delegated the advisory committee to study the issue. Philip Morris knew full well that the chances of a menthol ban being implemented by regulation, rather than by legislation, are minimal.

Now that TPSAC has squandered its opportunity to direct the FDA one way or another, the chances of a menthol cigarette ban become even lower.

And it is now eminently clear that the lack of a recommendation by the TPSAC was not a simple omission or oversight; it was an intentional act of bureaucratic inertia and weakness.

Tuesday, July 19, 2011

An article in the Charleston Gazette highlights my criticism of the Kanawha County study which concluded that the county's smoking ban resulted in a sustained decline in heart attacks during the period 2000-2008.

Here are the details: Kanawha County (West Virginia) had virtually no clean indoor air protection in place until January 1, 2004. Prior to that time, smoking was allowed in most workplaces and in up to 50% of designated seating in restaurants. As of January 1, 2004, smoking was prohibited entirely in workplaces, including restaurants.The investigators examined hospital admission rates for acute coronary syndrome from 2000 through 2008, thus including four years prior to the smoking ban and four years following the smoking ban. Had the smoking ban led to a decline in acute coronary syndrome admissions, one would have seen such a decline during the 2004-2008 period compared to the 2000-2004 period.

The data, however, show no such decline. Instead, the data show a steady decline in acute coronary syndrome (ACS) rates that is consistent throughout the study period and does not accelerate after the implementation of the smoking ban. The study therefore demonstrates that a stringent smoking ban implemented in Kanawha County was not associated with any significant change in hospital admissions for acute coronary events, refuting the conclusions of other studies which reported such effects.

Curiously, this is not what the study authors chose to report in their conclusions. As if pulling a silver lining out of a dark cloud, the investigators instead conclude as follows: "In the presence of a CIAR [clean indoor air regulation], a consistent decline in incidence of hospital admissions for ACS can be demonstrated." The same conclusion is reiterated later in the paper: "In conclusion, our results demonstrate that from 2000 through 2008, the rate of hospital admissions for ACS has consistently declined in Kanawha County in the presence of an existing CIAR."

I argued that to associate the decline in ACS admission rates during this time period with the almost non-existent smoking restrictions is ludicrous. First of all, the paper does not show any change in the admission rate from before to after the weak county regulations. They had in fact been in effect since 1995. So unless the paper went back to about 1990, it could not possibly draw conclusions about the relationship between the county regulation passed in 1995 and any change in ACS admission rates.

Furthermore, the so-called clean indoor air regulation in the county is meaningless. Restaurants were allowed to designate up to 50% of their seating for smoking. That isn't a smoking ban. It's essentially no regulation. In almost every other study of this kind, such a regulation would be considered the absence of a smoking ban. Obviously, a 50% designated smoking area policy is not going to protect customers from secondhand smoke exposure. This has been proven in multiple studies.

I concluded that this story shows how seriously the quality of tobacco control science has degraded. I also offered a $100 reward to any anti-smoking group that had the integrity to report the actual study findings. Needless to say, there were no takers and my money remains safe.

The Rest of the Story

I think this article does a fine job of articulating this story and describing why it is that the conclusions of the study are unsupported by the actual study findings.

For example, the article astutely points out that: "The authors of the study do state in their findings that no significant changes were recorded "between, before and after the removal of smoking areas in restaurants," in 2004.

If this is the case, then how can the article possibly conclude that the smoking ban (which was implemented in 2004) led to a decline in the rate of acute coronary syndrome admissions?

The answer is: it can't. That it draws this conclusion anyway is essentially a sleight of hand. It is scientifically faulty at best and disingenuous at worst.

Not unexpectedly, for being willing to criticize anti-smoking research on scientific grounds, I was accused (in the comments section) of being a paid tobacco industry lobbyist. Well then, I guess I'll be excitedly anticipating the receipt of my next paycheck.

Monday, July 18, 2011

Under a new smoker discrimination policy being implemented by the Auckland District Health Board, 35% of current nurses will no longer be eligible to work for the Health Board. The policy precludes smokers from being employed as new hires.

According to the article: "A nurses' union is accusing Auckland's District Health Board of discrimination for considering not hiring smokers. The board, which employs more than 10,000 people, has instructed a proposal be drawn up that would see prospective health workers who smoke turned away. ADHB Executive Director of Nursing Taima Campbell, who proposed the original idea, said health workers had a responsibility to be positive role models. ... The Nurses Organisation says 35% of its members smoke, and it will oppose the policy."

A Health Board member defended the decision, arguing that: "We need our staff to be good role models and not smoke themselves."

The nurses union is opposing the policy. More than one in three nurses in Auckland are smokers.

The Rest of the Story

Unlike here in the U.S., nurses in New Zealand are standing up for their employment rights. The nurses union is rightly noting that the proposed policy represents employment discrimination and that it goes against everything they believe about equal opportunity.

In addition, the union made it clear that the policy will result in less qualified nurses being hired, since the smoking rate among nurses is 35%. You can't eliminate one-third of potential employees arbitrarily and expect to end up with the most highly qualified work force. In fact, you will not have the most highly qualified work force. You will be sacrificing nursing quality and ultimately, patient care.

The Health Board seems to believe that nurses must be good role models. So are they also refusing to hire obese or overweight nurses? Are they refusing to hire nurses who don't wear seat belts? Are they taking a careful sexual history of prospective employees to make sure that their nurses set a good example in that regard? Are they inquiring about marital fidelity? Surely, if you are going to be a good role model for others, you wouldn't want to have someone who is cheating on his or her spouse. Are they also inquiring about speeding tickets, failure to pay taxes, history of misdemeanor offenses, and eating habits?

Friday, July 15, 2011

According to an article on the WABI-TV web site, the FDA is awarding a $2.1 million grant to the state of Maine to help enforce laws to prevent the sale of tobacco to minors.

Dr. Lawrence Deyton, Director of the FDA's Center for Tobacco Products, says Maine has been awarded a contract that could be worth as much as $2.1 million dollars. The money is to help enforce FDA tobacco product laws and regulations. ... "This additional money into the state to help with our inspections of retailers to ensure that there aren't any underage sales of tobacco to minors is a huge step in the right direction for Maine." The contract also provides the state with new resources as well as the authority to inspect retailers and collect evidence needed to take action when the law is broken. ... "It's the retailers who are on the front lines and who can truly be the decisive factor in helping to protect kids from starting to use tobacco," Dr. Deyton told the crowd in Augusta."

The Rest of the Story

This is a waste of money. Enforcement of youth access laws has been demonstrated to be an ineffective strategy to prevent youth smoking. A meta-analysis of multiple studies of youth access laws found no relationship between the reported compliance rates and the prevalence of youth smoking. The article concluded that: "Given the limited resources available for tobacco control, as well as the expense of conducting youth access programs, tobacco control advocates should abandon this strategy and devote the limited resources that are available for tobacco control toward other interventions with proven effectiveness."

It is unfortunate that the FDA Center for Tobacco Products is embracing this ineffective strategy, rather than evidence-based practices which have been proven effective in reducing youth smoking.

One reason why youth access laws do not work is that cigarette purchase is just one of many sources of cigarettes for youth smokers. In fact, research has shown that only about half of youth smokers purchase their own cigarettes in stores. Thus, even if all sale of tobacco to youths were halted, it would not necessarily prevent youths from being able to obtain cigarettes.

Moreover, compliance checks are a poor indication of actual sale of tobacco to minors. The youths used in these checks are often nonsmokers and it is easy for clerks to recognize that these are not legitimate purchase attempts. Furthermore, the youths are instructed to tell the truth, something they don't need to do in "real life." Thus, even when very high compliance rates can be achieved, this does not necessarily mean that it is difficult for youth to buy or obtain cigarettes.

That youth access laws are so ineffective is evidenced by the fact that the tobacco companies have long supported this approach. They realized long ago that youth access restrictions offer very little obstacle to cigarette smoking by youth.

Hopefully, the FDA will not waste millions of dollars like this in other states as well.

Wednesday, July 13, 2011

More research, this time published in the journal Human Brain Mapping, suggests that graphic warning labels on cigarette packs will be far less effective in deterring smokers than is being touted by anti-smoking groups and politicians. An article published online ahead of print reports that smokers who are addicted to cigarettes and are deprived of being able to smoke for a short time are unresponsive to fear warnings about the health effects of smoking.

According to a Bloomberg Newssummary of the article: "Images of corpses and cancerous lungs on cigarette packs may do little to deter nicotine addicts, judging from new research on how smokers’ brains work. The brain’s fear center becomes desensitized in heavy smokers who haven’t been allowed to light up for 12 hours, a team of doctors in Germany found in a study published today. ... “In those who stop smoking, the activity of the fear center has been lowered so much that they are not very receptive to the scary photos,” Rene Hurlemann, a doctor at the Bonn University Clinic in Germany and one of the study’s authors, said in a statement. Hurlemann and his colleagues recruited 28 young volunteers who consumed an average of 17 cigarettes a day and had used tobacco for nine years, and the same number of non-smokers. The groups were shown images of happy, neutral and fearful faces while researchers recorded their brain activity. They responded in similar ways until the organizers deprived the smokers of tobacco. After just a few hours of deprivation, the smokers’ brains were less responsive to fearful faces, the researchers found."

The Rest of the Story

This research adds to a body of psychology and neurophysiology research which suggests that graphic warning labels on cigarette packages will have very little effect in deterring smoking among existing smokers who are addicted to cigarettes.

The findings of this study are in line with the opinion that I expressed in a Bloombergnews story about cigarette warning labels, which is featured on the same page as the story about this study: "Michael Siegel, an associate professor at the Boston University School of Public Health, talks about new U.S. government requirements for cigarette warning labels. Images of a corpse and cancerous lungs are among nine graphic warnings that tobacco companies must start placing on cigarette packs sold in the U.S. next year. Siegel speaks with Carol Massar and Matt Miller on Bloomberg Television's 'Street Smart.'"

Monday, July 11, 2011

A report by the research firm IBISWorld estimates that the graphic warning labels to be placed on cigarettes staring next year will reduce cigarette consumption by no more than 1%, according to an Associated Pressarticle.

According to the article: "The nation's top tobacco companies' sales aren't expected to go up in smoke despite new grisly warning labels that are set to appear on U.S. cigarettes packs next year. The graphic labels, which were released in June by the Food and Drug Administration and include an image of rotting teeth and gums, will cause a decline of less than one percent in overall U.S. tobacco revenues in 2013, according to a recent analysis by research firm IBISWorld. An average person smokes fifteen cigarettes a day at a cost of about $1,500 per year, which translates to about $300 million in lost revenue. That's only a fraction of the estimated $43.8 billion in revenue for the tobacco industry in 2013, the firm's calculation show."

The IBISWorld analyst predicted that "in the near term, it won't have much of an impact."

The Rest of the Story

This analysis comports with my own evaluation of the likely impact of the warning labels, which I opined last week would be minimal. However, politicians (like Senator Lautenberg) and anti-smoking organizations (like the Campaign for Tobacco-Free Kids and World Health Organization) have been boasting about how much of an impact these warning labels will have.

Sadly, the warning labels are the strongest aspect, and only real public health benefit of the FDA Tobacco Act. There is nothing else in the legislation which will have any substantial positive public health impact. And the positive effect of the warning labels is estimated to be quite minimal.

The one substantial effect which these warning labels will have, however, is to completely immunize the tobacco industry against litigation. No jury is going to find the tobacco companies responsible, or even partly responsible, for damage caused by their products when these companies can argue that consumers are adequately warned of the product's dangers by virtue of these large warning labels.

I believe that for the industry, the benefits of virtual immunity against future litigation will outweigh the one percent or so decline in cigarette sales.

The FDA Tobacco Act remains, in my opinion, one of the worst deals ever agreed to by a public health organization.

Thursday, July 07, 2011

A new study published in the current issue of Preventing Chronic Disease: Public Health Research, Practice, and Policy finds no evidence of any significant decline in acute coronary syndrome (heart attacks and unstable angina) after implementation of a strong workplace and restaurant smoking ban in Kanawha County in 2004.

Kanawha County (West Virginia) had virtually no clean indoor air protection in place until January 1, 2004. Prior to that time, smoking was allowed in most workplaces and in up to 50% of designated seating in restaurants. As of January 1, 2004, smoking was prohibited entirely in workplaces, including restaurants.The investigators examined hospital admission rates for acute coronary syndrome from 2000 through 2008, thus including four years prior to the smoking ban and four years following the smoking ban. Had the smoking ban led to a decline in acute coronary syndrome admissions, one would have seen such a decline during the 2004-2008 period compared to the 2000-2004 period.

The data, however, show no such decline. Instead, the data show a steady decline in acute coronary syndrome (ACS) rates that is consistent throughout the study period and does not accelerate after the implementation of the smoking ban.

Here are the actual figures:

Prior to the smoking ban (2000-2004): Age-adjusted rate of ACS hospital admissions declined by 20.3%, or 4.1% per year.

After the smoking ban (2004-2008): Age-adjusted rate of ACS hospital admissions declined by 21.2%, or by 4.2% per year.

Thus, there was no change in the trend in ACS admissions after implementation of the strong smoking ban.

The authors acknowledge this finding: "We did not find additional significant change between, before, and after the removal of smoking areas in restaurants (the key change in the CIAR revision that took effect January 1, 2004) after accounting for the sustainable decline of ACS hospitalizations since the 2000 regulation revision (Table 1)."

They quantify the change in ACS admission rates associated with the smoking ban. The relative risk of ACS admission associated with the smoking ban was 1.02 (95% confidence interval, 0.92 to 1.12). Since the confidence interval crosses 1.0, this means that there was no significant effect of the smoking ban on ACS admission rates.

In summary, this study demonstrates that a stringent smoking ban implemented in Kanawha County was not associated with any significant change in hospital admissions for acute coronary events, refuting the conclusions of other studies which reported such effects.

The Rest of the Story

Miraculously, this is not what the study authors chose to report in their conclusions. As if pulling a silver lining out of a dark cloud, the investigators instead conclude as follows: "In the presence of a CIAR [clean indoor air regulation], a consistent decline in incidence of hospital admissions for ACS can be demonstrated."

The same conclusion is reiterated later in the paper: "In conclusion, our results demonstrate that from 2000 through 2008, the rate of hospital admissions for ACS has consistently declined in Kanawha County in the presence of an existing CIAR."

This is an incredibly disingenuous sleight of hand.

The analysis tested a specific hypothesis: Was the smoking ban (implemented on January 1, 2004) associated with a significant decline in ACS hospital admissions). The analysis included a specific regression coefficient to test for this effect. The coefficient was close to zero and was not statistically significant, indicating that the smoking ban had no effect on ACS hospital admissions.

But instead of simply concluding that they failed to find any significant effect of the smoking ban on acute coronary event admission rates, the authors chose to spin the paper as having found that in the presence of a clean indoor air regulation of some kind (yes, a very weak ordinance was in effect as early as 1995), the rate of ACS hospital admissions dropped consistently over time.

Well of course the ACS hospital admissions dropped during the study period! These rates are declining everywhere. Cardiovascular disease admission rates have dropped everywhere during the past decade. There are major secular changes taking place in coronary artery disease medical management and treatment, including the availability of cholesterol-lowering statin drugs, better control of hypertension, and improved surgical treatments such as angioplasty.

That coronary syndrome rates dropped in Kanawha County during the period 2000-2008 is a non-finding. I could have told you that without even looking at the data. It would have been absolutely striking to have found an increase in ACS admission rates during this time period.

To associate the decline in ACS admission rates during this time period with the almost non-existent smoking restrictions is ludicrous. First of all, the paper does not show any change in the admission rate from before to after the weak county regulations. They had in fact been in effect since 1995. So unless the paper went back to about 1990, it could not possibly draw conclusions about the relationship between the county regulation passed in 1995 and any change in ACS admission rates.

Furthermore, the so-called clean indoor air regulation in the county is meaningless. Restaurants were allowed to designate up to 50% of their seating for smoking. That isn't a smoking ban. It's essentially no regulation. In almost every other study of this kind, such a regulation would be considered the absence of a smoking ban. Obviously, a 50% designated smoking area policy is not going to protect customers from secondhand smoke exposure. This has been proven in multiple studies.

So this paper has pulled two sleight of hand tricks to make it look like a positive finding when in fact the main finding is a negative one. It's incredibly impressive to me to see this kind of manipulation take place in what is a very simple and straightforward study that fails to find any effect of a strong smoking ban on acute coronary event hospitalization rates.

I think it shows just how seriously the quality of tobacco control science has degraded.

A question: How many anti-smoking groups do you think are going to disseminate the findings of this study? I am so sure that not a single group will share these results with the public that I'm willing to bet $100 that no group [Missouri GASP is not eligible] which previously reported the results of a study showing a positive effect of a smoking ban in reducing ACS admissions will now report the result of this study which clearly shows no effect of a smoking ban in reducing ACS admissions.

If any group does report this negative finding, I'll donate my $100 prize offering to that organization. Believe me, I'm not rushing off to find my checkbook. This is a bet that is a sure thing. No anti-smoking group will report this finding because anti-smoking groups aren't interested in the truth. They are interested in results that are favorable to their cause.

This is the sad lesson that I have learned over the past few years. It is disillusioning to me and to my vision of the importance of scientific integrity in the practice of tobacco control in public health.

Wednesday, July 06, 2011

In a press release issued last week, Senator Frank Lautenberg (D-NJ) congratulated himself for the introduction of nine rotating graphic warning labels on cigarette packs, to be unveiled in March 2012, which resulted from the legislation he supported in 2009.

Senator Lautenberg boasted as follows: "For decades, Big Tobacco got away with slick marketing campaigns that fooled the public into thinking smoking was glamorous – and now we’re turning the tables on them. Each time a smoker reaches for a pack of cigarettes, the deadly truth will be staring them in the face. I applaud the FDA for breathing new life into our country’s efforts to alert the public to the lethal consequences of tobacco addiction. I've been working for over a decade to make these warning labels a reality, and I believe the FDA has taken a crucial step to make people – especially teenagers – think twice before lighting up."

The Rest of the Story

The key lack of insight in Senator Lautenberg's statement is highlighted in bold above: these graphic warning labels will confront smokers each time he or she reaches for a pack of cigarettes. In other words, it is too late. The smoker is already addicted to smoking. He or she has already made the decision to smoke. He or she has already purchased the cigarettes. He or she already has a craving to smoke, and is likely acting due to his or her cigarette addiction. Yet Lautenberg (and a number of anti-smoking groups) appear to believe that a large number of smokers are going to overcome their addiction to smoking simply by being reminded that cigarette smoking is harmful to their health.

This mentality has pervaded the tobacco control movement for too long. It just doesn't work. In 2011, people are not smoking because of lack of awareness that cigarettes are dangerous and could kill them. They are smoking despite that knowledge and awareness. That's the power of the addiction.

Unless and until Congress and anti-smoking groups discard the old dogma of the Health Belief Model (i.e., smokers will quit if only they are informed about the devastating health effects) and adopt a new model that is based on the recognition that smoking is a powerful addiction that does not respond to rational messages and rational decision-making, we will continue to make no more than marginal progress in the effort to promote smoking cessation and substantially reduce smoking rates and their associated morbidity and mortality.

I see a lot of self-congratulations going on among tobacco control groups and policy makers, but I see very little legislation or policy with teeth that will actually make a serious difference in smoking rates and therefore smoking-related morbidity and mortality. In fact, the present emphasis on ingredient disclosure and regulation, warning labels, youth access restrictions, and obstruction of safer competitive products are all working effectively to obscure the real solutions. This is exactly the way Philip Morris planned it. I stand in awe of their work, as the health groups and politicians fell for the trap hook, line, and sinker.

The authors further estimated the effects of treating a population with Chantix in terms of the number of adverse cardiovascular events that would occur compared to the number of smokers who would quit smoking because of the use of Chantix. The results were as follows:

"Varenicline increases the chances of a successful quit attempt by twofold compared with unassisted smoking cessation. However, at the population level, most smokers quit unassisted. The number needed to treat with varenicline for one additional person to successfully quit smoking is estimated to be 10 (95% CI 8–13). Assuming a baseline risk of serious adverse cardiovascular events of 5.57% per year (among smokers with stable cardiovascular disease), the number needed to harm (the number needed to cause one additional serious cardiovascular event) with varenicline is estimated to be 28 (95% CI 13 to 213) per year. The risk of additional serious adverse events associated with varenicline use includes the potential for serious neuropsychiatric symptoms such as depressed mood, agitation and suicidal thoughts."

Thus, for every 30 patients treated with Chantix, this article predicts that three people will quit smoking successfully due to the Chantix but that one person will have a serious cardiovascular event like a heart attack. In addition, an unknown number may experience severe neuropsychiatric effects such as suicidal ideation.

Given these tradeoffs, as well as the fact that there are other smoking cessation medications available and the overall long-term success rate with Chantix is dismal, it hardly seems justified to recommend that Chantix remain a mainstay of a national smoking cessation strategy on a population level.

The Rest of the Story

The public health impact of these findings is substantial. According to one of the study authors, as quoted in MedPage Today: "'In absolute terms, it is a small difference,' first author Sonal Singh, MD, of Johns Hopkins, told MedPage Today. 'However, when you consider the difference from a population perspective, you get a very different picture. It is estimated that 7 million people in the U.S. were using Chantix last year. If you apply our results to the total number of users, I estimate that there were 62,500 cardiac events that were linked to use of Chantix. That is not a small number, by any standards.'"

So in addition to the more than 200 suicides that have been linked to Chantix, Singh is now estimating that Chantix causes 62,500 serious cardiac events (e.g., heart attacks) per year. This is all in the name of helping one person quit smoking out of every 30 who are treated. While I suppose it is possible that the benefits of Chantix still outweigh the risks, it is difficult for me to see how, given these numbers. It is clear that in the short-term, the benefits of reducing cardiac risk due to quitting smoking is overshadowed by the increased risk of severe adverse cardiovascular events.

In contrast to the 62,500 serious cardiac events attributable to Chantix each year, the use of electronic cigarettes to quit smoking has been associated with zero serious adverse events.Nevertheless, the official policy recommendation of each of the following anti-smoking organizations is that Chantix should remain on the market while electronic cigarettes should be taken off the market until proven "safe and effective":

The Campaign for Tobacco-Free Kids;

The American Cancer Society;

The American Heart Association;

The American Lung Association;

Action on Smoking and Health;

The American Academy of Pediatrics; and

The American Legacy Foundation.

The glaring inconsistency in the policies of these anti-smoking groups is difficult to fathom, unless one also considers one other thing that each of these groups has in common:

All have or have had financial associations with Pfizer, the manufacturer of Chantix.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.